Warnings and Precautions

The adverse effects of Acthar are related primarily to its steroidogenic effects

Acthar may increase susceptibility to new infection or reactivation of latent infections

Suppression of the hypothalamic-pituitary-axis (HPA) may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g. trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA suppression after stopping treatment

Cushing’s syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms

Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Blood pressure, sodium and potassium levels may need to be monitored

Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy

Acthar can cause GI bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain gastrointestinal disorders. Monitor for signs of bleeding

Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression, and psychosis. Existing conditions may be aggravated

Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis

Prolonged use of Acthar may produce cataracts, glaucoma and secondary ocular infections. Monitor for signs and symptoms

Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH activity

There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver

Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients

Decrease in bone density may occur. Bone density should be monitored for patients on long-term therapy

Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

Adverse Reactions

Common adverse reactions for Acthar are similar to those of corticosteroids and include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain

Specific adverse reactions reported in IS clinical trials in infants and children under 2 years of age included: infection, hypertension, irritability, Cushingoid symptoms, constipation, diarrhea, vomiting, pyrexia, weight gain, increased appetite, decreased appetite, nasal congestion, acne, rash, and cardiac hypertrophy. Convulsions were also reported, but these may actually be occurring because some IS patients progress to other forms of seizures and IS sometimes mask other seizures, which become visible once the clinical spasms from IS resolve

FREE TRIAL OFFER ELIGIBILITY TERMS & CONDITIONS:

The Free Trial Offer Program is only for patients whose healthcare provider has diagnosed the patient with symptomatic sarcoidosis, who have not used H.P. Acthar® Gel (repository corticotropin injection) (currently or in the past), and who are covered by a commercial [private] insurance plan. A patient who is participating in Medicare, Medicaid, or any government-funded healthcare program is not eligible to participate in this program. The Free Trial Offer Program is valid for up to 12 vials of Acthar therapy over a 6-month period, prior to the expiration date. The patient agrees not to seek reimbursement from any third-party payor for all or any part of Acthar dispensed pursuant to this program. Void where prohibited by law. Patients must be 18 years of age or older to participate. This Program expires on December 31, 2018. Mallinckrodt reserves the right to rescind, revoke, or amend this Free Trial Offer Program at any time without notice. By participating in this program, you agree to these eligibility terms and conditions.